VENLAFAXINE RETARD CINFAMED 75 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take venlafaxine retard cinfamed

Do not take venlafaxine retard cinfamed

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking, or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking an irreversible MAOI with other medicines, such as venlafaxine, can cause serious or potentially life-threatening side effects. Also, you must wait at least 7 days after you stop taking venlafaxine before you take any MAOI (see also sections “Serotonin syndrome” and “Other medicines and venlafaxine retard cinfamed”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take venlafaxine retard cinfamed

• If you are taking other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and venlafaxine retard cinfamed”).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told you have an irregular heartbeat.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in the blood (hyponatraemia).
• If you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy and breastfeeding”).
• If you have a history of, or if a family member has had, mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behaviour.

Some medicines of the group to which venlafaxine belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Venlafaxine may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

Do not drink alcohol during treatment with venlafaxine retard cinfamed, as it may cause extreme tiredness and unconsciousness. Taking it with certain medicines and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment with antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with venlafaxine.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital directly.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered by venlafaxine. Therefore, the doses of your diabetes medicines may need to be adjusted.

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years. In addition, you should know that in patients under 18 years, there is an increased risk of adverse effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, confrontational behaviour, and irritability) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years when he decides that it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years are taking venlafaxine. Additionally, long-term safety with respect to growth, maturation, and cognitive and behavioural development has not been demonstrated.

Other medicines and venlafaxine retard cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor should decide whether you can take venlafaxine with other medicines.

Do not start or stop taking any medicines, including those bought without a prescription, herbal or plant-based remedies, before checking with your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with venlafaxine. Tell your doctor if you have taken any of these medicines in the last 14 days (MAOI: see section “What you need to know before you take venlafaxine retard cinfamed”).
• Serotonin syndrome:

A potentially life-threatening or syndrome-like condition called Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine),
• other medicines for treating depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium,
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity),
• medicines containing the antibiotic linezolid (used to treat infections),
• medicines containing moclobemide, a reversible MAOI (used to treat depression),
• medicines containing sibutramine (used for weight loss),
• medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain),
• medicines containing dextromethorphan (used to treat cough),
• medicines containing methadone (used for opioid addiction treatment or for severe pain treatment),
• medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methaemoglobin in the blood),
• products containing St John's Wort (also known as Hypericum perforatum, a herbal or plant-based remedy used to treat mild depression),
• products containing tryptophan (used for problems such as sleep and depression),
• antipsychotics (used to treat an illness with symptoms such as hearing, seeing, or feeling things that do not exist, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a tendency to withdraw).

The signs and symptoms of serotonin syndrome may include a combination of the following:

restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Tell your doctor immediately or go to the casualty department of the nearest hospital if you think you are experiencing serotonin syndrome.

Tell your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heartbeat).
• Antipsychotics such as thioridazine (see also “Serotonin syndrome” above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections).
• Antihistamines (used to treat allergies).

The following medicines may also interact with venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine).
• Haloperidol or risperidone (for treating psychiatric conditions).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Taking venlafaxine retard cinfamed with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3).

Do not drink alcohol during treatment with venlafaxine retard cinfamed. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take venlafaxine after discussing the potential benefits and risks to the unborn child with your doctor.

Make sure your midwife and/or doctor knows you are taking venlafaxine. When similar medicines (SSRIs) are taken during pregnancy, they may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you must contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, in addition to breathing problems, another symptom your baby may have when born is problems with feeding. If your baby has these symptoms when born and you are worried, contact your doctor and/or midwife who will be able to advise you.

If you take venlafaxine retard in the last trimester of pregnancy, there may be an increased risk of heavy vaginal bleeding after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxine so they can advise you.

Venlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor, and he will decide whether you should stop breastfeeding or stop the treatment with this medicine.

Driving and using machines

During treatment with venlafaxine, you may feel somnolent or dizzy. Do not drive or operate tools or machines until you know how the treatment with venlafaxine affects you.

venlafaxine retard cinfamed contains sucrose.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take venlafaxine retard cinfamed

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start you on a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take venlafaxine at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

If you have liver or kidney problems, talk to your doctor, as you may need to take a different dose of this medicine.

Do not stop taking this medicine without talking to your doctor (see section “If you stop taking venlafaxine retard cinfamed”).

If you take more venlafaxine retard cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see Taking venlafaxine retard cinfamed with other medicines).

The symptoms of a possible overdose may include rapid heartbeat, changes in the level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take venlafaxine retard cinfamed

If you miss a dose, take it as soon as you remember. However, if it is already the time for your next dose, skip the missed dose and take only a single dose as you would normally. Do not take a double dose to make up for missed doses. Do not take more than the daily dose of venlafaxine that has been prescribed for you in one day.

If you stop taking venlafaxine retard cinfamed

Do not stop taking your treatment or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks you no longer need venlafaxine, he may ask you to reduce the dose gradually before stopping treatment altogether. It is known that side effects occur when people stop using this medicine, especially when it is stopped abruptly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, tiredness, dizziness, unsteadiness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric shock, weakness, sweating, seizures, or symptoms similar to flu, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you how to gradually stop taking venlafaxine. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual over several months or more. If you experience any of these or other symptoms that are troublesome, consult your doctor for advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If any of the following effects occur, do not take more venlafaxine. Tell your doctor immediately, or go to the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 patients)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or swollen rash with itching, difficulty swallowing or breathing.

Rare (may affect up to 1 in 1,000 patients)

• Chest tightness, breathing sounds, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (elevated areas of reddened or pale skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.
• In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which can lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from the available data)

• Signs and symptoms of a condition called "stress cardiomyopathy" which may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other adverse effects that you should inform your doctor aboutare (the frequency of these adverse effects is included in the list below "Other adverse effects"):

• Cough, breathing sounds, and difficulty breathing that may be accompanied by an increased temperature.
• Tarry stools (deposits) or blood in stools.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, tingling, movement disorder (muscle spasms and stiffness), convulsions or seizures.
• Psychiatric problems, such as hyperactivity (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take venlafaxine retard cinfamed. If you interrupt treatment with venlafaxine retard cinfamed").
• Prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Do not worry if you notice small white granules or balls in your stools after taking this medicine. Inside the venlafaxine capsules, there are spheroids or small white balls that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulatethroughthestomach and intestines, venlafaxine is releasedlently. The "shell" of the spheroiddoes not dissolveand iseliminated in the stools. Therefore, although you seespheroids inthestools,thedose of the medicinehas beenabsorbed.

Other adverse effects that may occur:

Very common (may affect more than 1 in 10 patients)

• Dizziness, headache, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including night sweats).

Common (may affect up to 1 in 10 patients)

• Decreased appetite.
• Confusion, feeling strange, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremor, a feeling of restlessness or inability to remain seated or still, tingling, altered taste perception, increased muscle tone.
• Visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased urination frequency, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 patients)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, tarry stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms, and involuntary muscle movements.
• Mild changes in blood liver enzyme levels.

Rare (may affect up to 1 in 1,000 patients)

• Seizures or convulsions.
• Cough, breathing sounds, and shortness of breath that may be accompanied by a high temperature.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular, which can lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).

Very rare (may affect up to 1 in 10,000 patients)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

Frequency not known (cannot be estimated from the available data)

• Suicidal ideation and behavior; cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after treatment interruption (see section 2. "What you need to know before taking venlafaxine retard cinfamed").
• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxine sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; mild changes in blood liver enzyme levels, sodium, or cholesterol. Less frequently, venlafaxine may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of venlafaxine retard cinfamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in a dry place.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of venlafaxine retard cinfamed

• The active ingredient is venlafaxine (as hydrochloride). Each capsule contains 75 mg of venlafaxine (as venlafaxine hydrochloride).
• The other ingredients are sugar spheres 20 (sucrose and cornstarch), stearic acid, ethylcellulose, and talc. The capsule ingredients are: gelatin and titanium dioxide (E-171)

Appearance of the product and package contents

venlafaxine retard cinfamed is presented in the form of hard prolonged-release capsules. The capsules with white opaque cap and body are made of hard gelatin and contain white or off-white pellets.

venlafaxine retard cinfamed is presented in Al/PVDC-PVC/PVDC blisters.

Each package contains 30 or 500 (clinical package) hard prolonged-release capsules.

Only some package sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Farmalider S.A.

Aragoneses, 2

28108 (Alcobendas) Madrid

Spain

O

Starpharma Ltd.

Industrial State

Half Far - Malta

O

VALPHARMA INTERNATIONAL S.p.A.

Via G. Morgagni, 2

61016 Pennabilli (Pesaro-Urbino)

Italy

O

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10.

Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this prospectus:May 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69162/P_69162.html

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